P017 – Programa de ensaio de proficiência de ensaio de vibração

ARTEFATO:

• Amostra desenvolvida que consiste em uma placa de alumínio (laranja), utilizando grampos (rosa) para fixá-la em um dispositivo de vibração em formato de U (azul).
• A massa total da amostra (placa de alumínio + grampos + placa base) é de 3,4 kg.
• A massa da placa de alumínio é de 0,4 kg.

NORMAS APLICÁVEIS:

• IEC 60068-2-6:2007 – Environmental testing – Part 2-6: Tests – Test Fc: Vibration (sinusoidal).
• IEC 60068-2-64:2008 + AMD1:2009 Environmental testing – Part 2-64: Tests – Test Fh: Vibration, broadband random and guidance.
• IEC 60601-1:2005 + AMD1:2012 + AMD2:2020 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
• IEC 60601-11:2015 + AMD1:2020 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
• ISO 80601-2-12:2020 Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators.
• ISO 80601-2-74:2017 Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment.
• ISO 80601-2-84:2020 Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment.

ÚLTIMA RODADA:

• 2023

PRÓXIMO RODADA:

• 2026

ESTABILIDADE DO ARTEFATO:

• CONTINENTAL (CRL 1321)

VALOR DA INSCRIÇÃO:

• será definida quando as inscrições forem abertas.

CADASTRO NO EPTIS:

• 1097904.

 

 

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